Maintenance olaparib (Lynparza) appeared to be associated with an overall survival benefit vs placebo in women with platinum-sensitive serous ovarian cancer and BRCA1 and BRCA2 mutations, according to an updated analysis of a phase II trial reported in The Lancet Oncology by Ledermann et al. Maintenance olaparib was previously reported to significantly prolong progression-free survival in the study.

Study Details

In the double-blind trial, 265 patients from 82 sites in 6 countries who had platinum-sensitive recurrent serous ovarian cancer and had received two or more courses of platinum-based chemotherapy and had responded to their latest regimen were randomized to receive oral maintenance olaparib at 400 mg twice daily (n = 136) or placebo (n = 129). The primary endpoint was progression-free survival; the current analysis of overall survival, a secondary endpoint, is from the third data analysis after more than 5 years of follow-up in the intent-to-treat population. The study was not statistically powered to assess overall survival; thus, the analysis is descriptive, and the P values are nominal.